Previous patent applications by the inventors herein, including U.S. application Ser. Nos. 10/737,466 and 10/837,827, and related applications, which are all incorporated by reference herein in their entireties, disclose and relate to a stapling device for use in the fixation of endovascular grafts to the walls of vessels. The present disclosure builds on those teachings by providing, in accordance with certain aspects, novel valve structures and surgical instruments for replacing a failing bioprosthetic aortic valve using a minimally invasive transvascular approach. The present disclosure also discloses methods for replacing a failing bioprosthetic aortic valve using a minimally invasive approach. The disclosure utilizes not only staplers of the type described in the previously referenced applications, but additional devices which are novel to the present disclosure.
More specifically, this invention relates to structures, methods and stapling devices for replacement of bioprosthetic aortic valves. The replacement structures, methods, and stapling devices facilitate the rapid durable joining of a new aortic valve to the annulus structure of a preexisting damaged bioprosthetic aortic valve with significantly reduced risk to the patient as compared to conventional surgical open heart methods.
Many patients who suffer from severe aortic valve disease have undergone surgery to replace their original aortic valve in order to restore proper cardiac function. Such replacement bioprosthetic valves may be commonly formed from porcine aortic valves or modified bovine pericardium, each of which have been used in many cases in the presence of certain indications. Such indications include patient age over 70, contraindication to lifelong systemic anticoagulation, or because of the known lower rates of thromboembolic complications associated with these types of valves.
Bioprosthetic valves, however, have diminished durability compared to mechanical valves and frequently fail during the patient's lifetime because of stenosis due to leaflet fusion and or calcification, or incompetence due to leaflet tears and degeneration. Subsequent surgical intervention to replace these failed valves is associated with very high morbidity and mortality rates because of the generally poor medical condition of the subjects. This makes it necessary to seek less intrusive methods to achieve this valve replacement. The present invention provides for a less invasive option for replacing a failing bioprosthetic aortic valve while addressing the need to actively fix the replacement valve so that it is not moved by the pressure of blood flow. Attempts to hold these new valves in place using stents have not provided durable results for obvious reasons.